Back to resultsGALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesaglitazar
Pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
Eligibility Criteria
Inclusion Criteria: Provision of a written informed consent Men or women who are >= 18 years of age Female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control. Completed the last two visits of the randomized treatment period in GALLANT 6 Exclusion Criteria: Type 1 diabetes New York Heart Association heart failure Class III or IV Treatment with chronic insulin History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells) Creatinine levels of above twice the normal range Creatine kinase of above 3 times the upper limit of normal Previous enrollment in this long-term extension study Any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
Sites / Locations
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Outcomes
Primary Outcome Measures
Adverse events
Laboratory variables
Physical examination
Cardiac evaluation
Hypoglycemic events
Electrocardiogram
Vital signs (blood pressure and pulse)
Body weight
Secondary Outcome Measures
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
C-reactive protein (CRP)
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00226330
Brief Title
GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Official Title
A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tesaglitazar
Other Intervention Name(s)
Galida
Intervention Description
(0.5 or 1 mg)
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
(15, 30 or 45 mg)
Primary Outcome Measure Information:
Title
Adverse events
Title
Laboratory variables
Title
Physical examination
Title
Cardiac evaluation
Title
Hypoglycemic events
Title
Electrocardiogram
Title
Vital signs (blood pressure and pulse)
Title
Body weight
Secondary Outcome Measure Information:
Title
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Title
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Title
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
Title
C-reactive protein (CRP)
Title
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Title
Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of a written informed consent
Men or women who are >= 18 years of age
Female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
Completed the last two visits of the randomized treatment period in GALLANT 6
Exclusion Criteria:
Type 1 diabetes
New York Heart Association heart failure Class III or IV
Treatment with chronic insulin
History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
Creatinine levels of above twice the normal range
Creatine kinase of above 3 times the upper limit of normal
Previous enrollment in this long-term extension study
Any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galida Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
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Birmingham
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Moron
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Argentina
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Quilmes
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Rosario
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Curitiba
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Brazil
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Edmonton
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Victoria
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Dartmouth
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Halifax
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Windsor
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Brampton
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Etobicoke
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Kingston
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Niagara Falls
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Oshawa
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Toronto
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Chicoutimi
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Canada
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Longueuil
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Canada
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Montreal
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Canada
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Trois-Rivières
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Quebec
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Canada
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Helsinki
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Finland
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Kauniainen
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Finland
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Kuopio
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Finland
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Pietarsaari
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Finland
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Pori
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Finland
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Tampere
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Finland
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Guadalajara, Jalisco.
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Mexico
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México, D.F.
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Mexico
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Nuevo León, Monterrey
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Mexico
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Puebla, Mexico
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Mexico
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Torreon
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Mexico
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Zapopan
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Mexico
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Belfast
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United Kingdom
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Cardiff
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United Kingdom
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Co Antrim N Ireland
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United Kingdom
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Co. Wexford, Ireland
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United Kingdom
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Dublin
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Kent
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United Kingdom
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Leeds
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United Kingdom
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Mid Glamorgan
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United Kingdom
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Pembrokeshire
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United Kingdom
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Plymouth
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United Kingdom
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Reading
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United Kingdom
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Surrey
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United Kingdom
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Wiltshire
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United Kingdom
12. IPD Sharing Statement
Learn more about this trial
GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
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